Maribavir (Livtencity) Form

Maribavir (Livtencity™) is a cytomegalovirus (CMV) pUL97 kinase inhibitor. FDA Approved Indication(s) Livtencity is indicated for the treatment of adults and pediatric patients (12 years of age and older and weighing at least 35 kg) with post-transplant CMV infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir, or foscarnet. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Livtencity is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Post-Transplant CMV Infection (must meet all):

1. Diagnosis of CMV infection following hematopoietic stem cell transplant or solid organ transplant (e.g., kidney, lung, heart, liver, pancreas, intestine);
2. Age ≥ 12 years;
   3. Weight ≥ 35 kg;
   4. Failure to achieve > 1 log10 decrease in CMV DNA level in whole blood or plasma after a ≥ 14-day trial of one of the following: ganciclovir, valganciclovir, cidofovir, foscarnet;
3. Member does not have CMV disease involving the central nervous system (including the retina);

4. Livtencity is not prescribed concurrently with ganciclovir or valganciclovir;

   7. Dose does not exceed (a, b, or c): a. 800 mg (4 tablets) per day; b. If co-administered with carbamazepine: 1,600 mg (8 tablets) per day; c. If co-administered with phenytoin or phenobarbital: 2,400 mg (12 tablets) per day. Approval duration: 8 weeks Page 1 of 5

   CLINICAL POLICY Maribavir B. Other diagnoses/indications (must meet 1 or 2):

5. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
6. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Post-Transplant CMV Infection (must meet all):
7. Currently receiving medication via Centene benefit, or documentation supports that member is currently receiving Livtencity for a covered indication and has received this medication for at least 30 days;
8. Member is responding positively to therapy;
   3. Member has not received ≥ 8 weeks of therapy;
   4. Livtencity is not prescribed concurrently with ganciclovir or valganciclovir;
   5. If request is for a dose increase, new dose does not exceed (a, b, or c): a. 800 mg (4 tablets) per day; b. If co-administered with carbamazepine: 1,600 mg (8 tablets) per day; c. If co-administered with phenytoin or phenobarbital: 2,400 mg (12 tablets) per day. Approval duration: up to 8 weeks total B. Other diagnoses/indications (must meet 1 or 2):

9. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or Page 2 of 5

   CLINICAL POLICY Maribavir

10. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid. III. Diagnoses/Indications for which coverage is NOT authorized:
    A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
    IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key CMV: cytomegalovirus FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives
    Drug Name Dosing Regimen ganciclovir (Cytovene®) valganciclovir (Valcyte®) 900 mg PO BID cidofovir (Vistide®) foscarnet (Foscavir®) 5 mg/kg IV q12 hours 5 mg/kg IV once per week 90 mg/kg IV q12 hours or 60 mg/kg IV q8 hours Dose Limit/ Maximum Dose 10 mg/kg/day 1,800 mg/day 5 mg/kg/week 180 mg/kg/day Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. *Off-label Appendix C: Contraindications/Boxed Warnings None reported V. Dosage and Administration
    Indication Post-transplant CMV infection Dosing Regimen • 400 mg PO BID or • If co-administered with carbamazepine: 1,600 mg (8 tablets) per day or • If co-administered with phenytoin or phenobarbital: 2,400 mg (12 tablets) per day Maximum Dose 2,400 mg/day VI. Product Availability
    Tablet: 200 mg Page 3 of 5

    CLINICAL POLICY Maribavir VII.